# Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance), Division 3.1: TEST REPORT

Extent: E+W+S+N.I.

The report must include the following information:
Test substance:
common name, chemical name, CAS number, structural formula (indicating position of the label(s) when radiolabelled material is used) and relevant physical-chemical properties;
purity (impurities) of test substance;
radiochemical purity of labelled chemical and molar activity (where appropriate).
Reference substances:
chemical name and structure of reference substances used for the characterisation and/or identification of transformation products
Test sediments and waters:
location and description of aquatic sediment sampling site(s) including, if possible, contamination history;
all information relating to the collection, storage (if any) and acclimation of water-sediment systems;
characteristics of the water-sediment samples as listed in Table in section 1.8.2.2.
Test conditions:
test system used (e.g. flow-through, biometer, way of ventilation, method of stirring, water volume, mass of sediment, thickness of both water and sediment layer, dimension of test vessels, etc.)
application of test substance to test system: test concentration used, number of replicates and controls mode of application of test substance (e.g. use of solvent if any), etc.
incubation temperature;
sampling times;
extraction methods and efficiencies as well as analytical methods and detection limits;
methods for characterisation/identification of transformation products;
deviations from the test protocol or test conditions during the study.
Results:
raw data figures of representative analyses (all raw data have to be stored in the GLP-archive);
repeatability and sensitivity of the analytical methods used;
rates of recovery (% values for a valid study are given in section 1.7.1);
tables of results expressed as % of the applied dose and in mgkg-1 in water, sediment and total system (% only) for the test substance and, if appropriate, for transformation products and non-extractable radioactivity;
mass balance during and at the end of the studies;
a graphical representation of the transformation in the water and sediment fractions and in total system (including mineralisation);
mineralisation rates;
half-life, DT50 and, if appropriate, DT75 and DT90 values for the test substance and, where appropriate, for major transformation products including confidence limits in water, sediment and in total system;
an assessment of the transformation kinetics of the test substance and, where appropriate, the major transformation products;
a proposed pathway of transformation, where appropriate;
discussion of results.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2I/division/C.24/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2I/division-C.24/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.